EBA One Nailing System

Rod, Fixation, Intramedullary And Accessories

CITIEFFE S.r.l.

The following data is part of a premarket notification filed by Citieffe S.r.l. with the FDA for Eba One Nailing System.

Pre-market Notification Details

Device IDK183666
501k NumberK183666
Device Name:EBA One Nailing System
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant CITIEFFE S.r.l. Via Armaroli, 21 Calderara Di Reno,  IT 40012
ContactStefano Pullega
CorrespondentStefano Pullega
CITIEFFE S.r.l. Via Armaroli, 21 Calderara Di Reno,  IT 40012
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
501k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-27
Decision Date2019-11-14

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.